A trial looking at intermittent versus continuous hormone therapy in advanced prostate cancer (EORTC 30985)

Please note this trial is no longer recruiting patients.

This trial is comparing intermittent hormone therapy with continuous hormone therapy for advanced prostate cancer.

Advanced prostate cancer can be treated with the hormonal drugs bicalutamide (eg Casodex) and goserelin (eg Zoladex).

But the treatment has side effects, which can be very difficult for some men. Stopping and starting the drugs, rather than taking them all the time, may reduce side effects. This trial is looking into stopping the drugs after 7 months, and only starting again if symptoms reoccur. The trial is to see if this treatment is as effective in controlling prostate cancer as having hormone treatment all the time.

Recruitment

Start 01/01/1999

End 01/09/2008

Phase

Phase 3

Who can enter

You can enter this trial if

You have been diagnosed with prostate cancer
Your prostate cancer has spread to your bones or another body organ
You have not had hormone treatment for at least 1 year

You cannot enter this trial if

Your cancer has spread to the spinal cord
You are having chemotherapy
You are having radiotherapy
You have had surgery to remove your testicles (orchidectomy)

Trial design

This trial is recruiting about 1,500 patients over 6 years. It is an international trial.

All patients will have monthly goserelin injections and daily bicalutamide tablets for 7 months. The trial is then randomised. The people taking part are put into 2 different treatment groups by a computer:

Group 1 will continue to have the injections and tablets as before. Treatment will continue as long as your cancer is controlled.

Group 2 will stop treatment. You will be closely monitored by your doctors and will restart treatment if there are signs that your cancer has started to grow again. If this happens, you will have another 7 months of treatment and so on.

The doctors will use your PSA blood test results together with any symptoms such as pain, increased difficulty passing urine, or blood in urine, to monitor your cancer.

Hospital visits

When receiving treatment, you will have to go to hospital once a month for an injection and blood tests. If you are being monitored, you will still be asked to go for regular blood tests and check ups. Everyone in the trial will be asked to go to follow up appointments in outpatients every 6 months.

Side effects

Hormone therapy does have side effects. These can include hot flushes, impotence, and breast tenderness. There is more information about the side effects of hormone therapy on CancerHelp UK.